A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas
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| ClinicalTrials.gov Identifier: NCT02147197 |
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Recruitment Status :
Completed
First Posted : May 26, 2014
Results First Posted : April 5, 2019
Last Update Posted : April 30, 2019
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leiomyoma Uterine Hemorrhage | Drug: Ulipristal acetate (UPA) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 157 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas |
| Actual Study Start Date : | March 31, 2014 |
| Actual Primary Completion Date : | March 29, 2016 |
| Actual Study Completion Date : | March 29, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Bleeding
Drug Information available for:
Ulipristal acetate
| Arm | Intervention/treatment |
|---|---|
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Experimental: UPA 5 mg
Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks.
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Drug: Ulipristal acetate (UPA)
UPA tablet Drug: Placebo Matching placebo tablet. |
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Experimental: UPA 10 mg
UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks.
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Drug: Ulipristal acetate (UPA)
UPA tablet Drug: Placebo Matching placebo tablet. |
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Placebo Comparator: Placebo
Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks.
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Drug: Placebo
Matching placebo tablet. |
Primary Outcome Measures :
- Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment [ Time Frame: Last 35 consecutive days on treatment in the 12-week Treatment Period ]Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.
- Time to Absence of Bleeding on Treatment [ Time Frame: From first dose up to the end of the 12-week Treatment Period ]Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.
Secondary Outcome Measures :
- Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment [ Time Frame: Day 11 through the end of the 12-week Treatment Period ]Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), starting from Day 11 through the end of the 12-week Treatment Period.
- Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period [ Time Frame: Baseline (Day 1-4) to the end of 12-week Treatment Period ]The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Females with abnormal uterine bleeding associated with leiomyomas were treated in this study. |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pre-menopausal women, 18-50 years, inclusive.
- Cyclic abnormal uterine bleeding (heavy or prolonged).
- Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
- Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
- Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia
Exclusion Criteria:
- History of uterine surgery that would interfere with the study endpoints.
- Known coagulation disorder including bleeding disorder or clotting disorder.
- History of, or current uterine, cervix, ovarian, or breast cancer.
- Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal rang
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147197
Locations
Show 28 study locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Anna Chan | Allergan |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT02147197 |
| Other Study ID Numbers: |
UL1309 |
| First Posted: | May 26, 2014 Key Record Dates |
| Results First Posted: | April 5, 2019 |
| Last Update Posted: | April 30, 2019 |
| Last Verified: | April 2019 |
Additional relevant MeSH terms:
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Leiomyoma Myofibroma Uterine Hemorrhage Hemorrhage Pathologic Processes Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
Neoplasms, Connective Tissue Connective Tissue Diseases Uterine Diseases Ulipristal acetate Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female |